Thursday January 8, 2015 0 comments
LITTLETON - dBMEDx Inc., a privately-held, wireless medical device company, announced it has received clearance from the FDA to market its novel bladder scanner, the BBS Revolution, a device for the non-invasive measurement of bladder volume.
Bladder scanning is a critical component of a comprehensive catheter-associated urinary tract infection (CAUTI) prevention program, an area of intense focus for hospitals given recent Medicare penalties for hospitals with high CAUTI rates as part of the Medicare hospital-acquired condition (HAC) reduction program.
Under the program, the Centers for Medicare and Medicaid Services are reducing payments by 1 percent for hospitals with a high number of HACs, including CAUTIs.
dBMEDx said the BBS Revolution is used to measure bladder volume and provide rapid, objective information on the necessity for a urinary catheter, the primary source of CAUTIs.
"Receiving FDA clearance is a pivotal step as we prepare to launch the BBS Revolution device," said David Shine, dBMEDx CEO.
"With the recent announcement from Medicare regarding penalties for hospital acquired conditions, hospitals will be looking for better, more effective tools to fight CAUTI and the BBS Revolution uniquely answers that need with unparalleled ease of use and accuracy."